CMC Completes New Single-Use Facility in Seattle, WA

CMC Biologics has finished construction on a disposable manufacturing facility at its Seattle, WA, site. The addition comes as part of a staged expansion plan to bolster capacity for cGMP manufacture of biopharmaceuticals.

The multipurpose, single-use facility will allow for early-phase clinical manufacture of a range of biopharmaceuticals including mAbs and other mammalian cell culture-based recombinant proteins. CMC Biologics partnered with Hyclone to supply the new disposable facility with processing equipment including a 100 L and two 500 L single-use bioreactors (SUBs) and disposable mixers.

Andy Walker, senior director of manufacturing, adds, "Disposable technology offers the advantages of increased flexibility and efficiency, decreased cross-contamination risks, and elimination of cleaning, sterilization, and other change-over procedures typically associated with traditional steel-tank facilities, while providing the same performance. Consequently, it provides a cost-effective strategy for reducing the speed to market for many biologics."

For other products where use of disposables is not feasible, CMC Biologics continues to offer its stainless-steel clinical and commercial cGMP manufacturing facilities. Besides Washington, the firm also has a plant in Copenhagen.

CMC Biologics is increasing its capacity with the addition of a second 3,000 L bioreactor train, identical to the existing line. Recent client demand has prompted initial steps toward build-out of a pre-existing structure anticipated to house two 5,000 L commercial-ready manufacturing lines. CMC Biologics also reports increasing headcount by more than 30% at its Seattle site to support the expansion.

CMC Biologics, a contract development and manufacturing organization, specializes in custom services for the scale-up and cGMP manufacture of protein-based therapeutics for preclinical, clinical trials, and commercial production. It has fully segregated microbial fermentation and mammalian cell culture suites and offers both stirred-tank and perfusion production processes. The company’s services include cell-line development using its CHEF1® system, process development, and comprehensive analytical testing.

Utilizing the regulatory sequences of the Chinese hamster EF-1a (CHEF1) gene, CMC says that its vectors promote constitutive high-level expression of recombinant proteins early in development. A variety of CHEF1 vectors are available with different selectable markers permitting expression of heterodimeric proteins as well as modification enzymes to improve product quality or expression levels, the company explains.